Coronavirus Prompting Reaction in Washington

The newest mutation to the coronavirus has had a massive impact in China and has prompted a reaction from the World Health Organization (WHO). The impact on makers of devices and diagnostics has been minimal so far, but the signs are that this could change quickly if the virus continues to proliferate.

The 2019-nCoV virus has prompted two press briefings by a U.S. federal government task force led by HHS Secretary Alex Azar, developments that followed a Jan. 31 declaration of emergency by WHO. Much of the concern about the virus is that it can be transmitted even from those who are asymptomatic, but the test for the virus developed by the U.S. Centers for Disease Control and Prevention has proven less than fully reliable.

Robert Redfield, director of the CDC, said in a Jan. 31 press briefing that the CDC test will return both positive and negative results on a patient who has been confirmed to carry the pathogen. The U.S. government response has been questioned, given that influenza is still proving more lethal, but Anthony Fauci of the National Institute of Allergy and Infectious Diseases said influenzas predictably fade as winter gives way to spring, whereas the trajectory of the new coronavirus is unknown.

The FDA recently issued an emergency use authorization for the CDC test, a reverse-transcriptase polymerase chain reaction test to be used with swabs from the upper and lower respiratory tracts. The CDC posted a press release two days later in which the agency said the test will initially be shipped to roughly 200 domestic sites and another 200 sites located in other nations. The test provides results within four hours, CDC said.

The Department of Health and Human Services posted a Feb. 6 announcement stating that HHS is taking submissions for diagnostics that would receive federal funding under the Biomedical Advanced Research and Development Authority (BARDA) program. This program requires that the test in question would have to be available on a platform already cleared by the FDA, and that the test would be ready for live use within 12 weeks of receipt of the award.

Congress Prods FDA for Assurances

Capitol Hill has demonstrated some concern about the impact of the coronavirus outbreak on the availability of medical products from China. Two members of the Senate, Florida Republican Marco Rubio and Connecticut Democrat Chris Murphy said in a Feb. 6 statement that they have a series of questions they would like answered by Feb. 18. Among the questions is whether the FDA has the resources to determine whether the impact of the coronavirus in China will affect the availability of drugs and devices for U.S. patients.

Murphy and Rubio noted that China is the source of the majority of active pharmaceutical ingredients used to produce drugs in the U.S., and that 10% of devices used in the U.S. are also imported from China. FDA commissioner Stephen Hahn said in the Feb. 7 press briefing that there was no evidence of any slowdown in the supply chain of the various products in question at that point in time, but he noted that the situation “is fluid” and that this could change in short order.

Perhaps as disturbing as any other recent event associated with the coronavirus is the discovery that more than four in 10 coronavirus patients in a hospital in China had contracted the virus while at the hospital. The majority of the patients presumed to have contracted the virus at the hospital site were employees of the hospital, although this single-site study might not reflect the broader experience in China. Nonetheless, the authors say that as many as 10 health care workers had presumably been infected by a single patient.

Nadcap-like Program Holds Promise for Recall Reduction and Enhanced Quality Assurance for Medtech Industry

Courtney A. Stevens, Esq. | Senior Attorney, Medmarc Loss Control

The Performance Research Insitute (PRI), the not-for-profit organization responsible for spearheading the Nadcap program in the aerospace industry, is now turning its focus on medtech and hoping to have the same dramatic results in quality improvement and supply chain management there that is attributed to it for aerospace.

Despite the multitude of standards and regulations that medical device and component part manufacturers are subject to, and indeed the corresponding barrage of audits to which they are subjected, leaders in the medical device industry working with PRI identified a real gap left by all—critical processes. That is, the specific, crucial processes manufacturers use to create their products—heat treating, welding, sterilization, plastics molding, printed circuit board assemblies, cable and wire harness, etc.—are not the focus of quality management system audits. Suppliers can pass all audits imposed on them by the FDA and their OEM-customers without ever having the integrity of their critical manufacturing processes assessed by subject matter experts. PRI’s MedAccred program endeavors to change that, and has already been adopted by some of the largest medical device OEMs (original equipment manufacturer) in the industry, including Johnson & Johnson, Stryker, and Philips Healthcare.

This article, Bringing Nadcap to the Medical Industry, discusses the prospects for the program in greater detail.